This invention relates to methods and kits for the treatment of medical disorders.
More particularly, it relates to methods and kits for the treatment of medical disorders utilizing reduced dosages of pharmaceutical without substantially reducing the effectiveness of the treatment.
Placebos (placebo means “I shall please”) have always been integral to the healing practices and medicine. In an editorial of the British Medical Journal explicitly recognized the placebo as a legitimate and useful component of medical therapeutics. The rise of the placebo-controlled clinical trial since the 1960's focused attention on the benefits of specific therapies compared with placebo effects. Recent decades of medical research have demonstrated the ubiquitous effects of placebos. Powerful placebo effects have been demonstrated in a range of common medical conditions, including peptic ulcers, irritable bowel, hypertension, low back pain, arthritis, anxiety disorders, depression and ADHD.
The mechanisms of placebo effects are poorly understood. It is known that there are no specific personality predictors of placebo response. Attributes of physicians, including their empathy and sense of confidence, can affect the magnitude of response. Responses to placebo in open trials are generally more robust than in controlled trials. Most importantly, the patient's expectation of improvement powerfully influences the response to placebo.
The results of a clinical trial involving children with Autism of secretin demonstrated no benefit of secretin over placebo. On several of the outcome measures, children in both the placebo and secretin groups showed significant improvement. Other studies of secretin have demonstrated robust placebo responses, including improvements in autistic behaviors and communication.
ADHD is a common condition in children, with estimated prevalence of 3% to 5%. Stimulants are widely used and very effective in the treatment of this condition. The most commonly prescribed stimulant is methylphenidate sold under the trade name Ritalin. Concerns about increasing sales of methylphenidate and potential side effects have generated public debate and controversy about overuse of stimulants.
Methylphenidate is effective in decreasing the symptoms of ADHD in 75% to 80% of children with this condition. Most children respond to a dose of 0.3 to 0.6 mg/kg/dose. At such low to moderate doses, about 10% to 30% of children experience one or more side effects, including loss of appetite, lack of weight gain, irritability, sleep disturbance, nausea or tics. These dose related side effects can be diminished or stopped by decreasing the doses of methylphenidate. Unfortunately, lower doses may be ineffective in treating the symptoms of ADHD.
There is extensive evidence from clinical trials of stimulants showing a robust placebo response in ADHD (Conners et al, 1996; Diamond et al, 1999). It is likely that the effect size is not a constant, but varies among individuals and also over time within individuals. A child who is a clinical responder to methylphenidate may be assumed to have a large component of his/her overall response due to specific effects of methylphenidate and a smaller component due to placebo. Thus it is desirable to take advantage of the “placebo effect” in the treatment of ADHD, as well as other disorders.